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Effect of Glucagon-like peptide-1 analogues on smoking consumption cessation in type 2 diabetes patients1: study protocol of a randomized, parallel -controlled clinical trial

Effect of Glucagon-like peptide-1 analogues on smoking consumption cessation in type 2 diabetes patients1: study protocol of a randomized, parallel -controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104651
Enrollment
Unknown
Registered
2025-06-20
Start date
2024-05-15
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type-2 diabete with smoking

Interventions

GLP-1 group:Application of GLP-1RAs drugs
DPP-IV group:Taking oral medications containing DPP-IV

Sponsors

Shanghai East Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Meet the diagnosis of type 2 diabetes mellitus; 2.Male and the age is between 18 and 75 years old; 3.Smoked for at least one year; 4.The Fagerstrom Test for Nicotine Dependence (FTND) score of >=4; 5.Understand the trial and will take part in it voluntarily, willing to sign a consent form; 6.Fit to use GLP1-RAs and DPP-IV inhibitors as the treatment but didn’t use them before;

Exclusion criteria

Exclusion criteria: 1.type 1 diabetes mellitus or special types of diabetes; 2.Diabetic patients with ketoacidosis and patients with severe diabetic complications; 3.Patients with severe heart, liver, kidney, brain, immune, and blood system diseases; 4.Patients with severe infection, malignant tumor, before and after surgery, and severe trauma; 5.Have a history of severe recurrent hypoglycemia; 6.Patients with severe gastrointestinal diseases (i.e., severe gastroparesis); 7.Previous history of pancreatitis or risk of pancreatitis; 8.Poor compliance, unwilling or unable to follow-up on time; 9.Severe psychiatric illness such as schizophrenia, paranoid psychosis, bipolar disorder, or intellectual disability; 10. Contraindications to magnetic resonance scanning (magnetic implants, pacemakers, claustrophobia, etc.)

Design outcomes

Secondary

MeasureTime frame
Functional MRI changes;Laboratory test indicators;Exhaled CO;General condition and adverse reactions;

Primary

MeasureTime frame
Fagerstrom Test of Nicotine Dependence (FTND) scores;

Countries

China

Contacts

Public ContactJun Song

Shanghai East Hospital

songjuntj@tongji.edu.cn+86 21 3880 4518

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026